FDA 510(k) Application Details - K974025

Device Classification Name	Bur, Surgical, General & Plastic Surgery   More FDA Info for this Device
510(K) Number	K974025
Device Name	Bur, Surgical, General & Plastic Surgery
Applicant	THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. PALM BEACH GARDENS, FL 33410 US Other 510(k) Applications for this Company
Contact	WILLIAM E ANSPACH III Other 510(k) Applications for this Contact
Regulation Number	878.4820   More FDA Info for this Regulation Number
Classification Product Code	GFF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/1997
Decision Date	07/06/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review